One New Product from SYNUTRA Approved--Totally 41 FSMP Approved in China

The State Administration for Market Regulation (SAMR) has approved the registration applications of  1 FSMP products on December 4, 2019, the detailed information are shown in the table below:

S.N.

Applicant

Product Name

Acceptance Number

Issuing Date

1

SYNUTRA INTERNATIONAL INC

优博瑞安 infant lactose free formula for special medical purpose

国食注申TY20180030

2019.12.4

Note: The registration certificate number and registration expiry date of the product is marked with "-" in table 1, and will be supplemented after relevant information are published

Summary and Analysis of the Approved FSMP in China

Up to now, totally 41 FSMP products have been approved in China. Among them, 13 products are domestic products while the remaining are foreign products. Relevant information are listed as below in table 1:

Table 1. The 41 approved FSMP products

S.N.

Applicant

Product name

Certificate number

Expiry date

1

SHS INTERNATIONAL LTD

Neocate infant amino acid formula (powder) for special medical purpose

国食注字TY20175001

2022.11.19

2

ABBOTT LABORATORIES S.A.

Similac infant partially hydrolyzed milk protein formula (powder) for special medical purpose

国食注字TY20175002

2022.11.19

3

ABBOTT LABORATORIES S.A.

Eleva Care infant partially hydrolyzed milk protein formula (powder) for special medical purpose

国食注字TY20175003

2022.11.19

4

HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.

Beingmate infant lactose free formula for special medical purpose

国食注字TY20180001

2023.2.12

5

SHS INTERNATIONAL LTD

Periflex infant phenylketonuria formula (powder) for special medical purpose

国食注字TY20185001

2023.2.26

6

MEAD JOHNSON B.V.

EnfaGentlease infant partially hydrolyzed milk protein formula (powder) for special medical purpose

国食注字TY20185002

2023.3.19

7

ABBOTT NUTRITION, ABBOTT LABORATORIES

Similac Neo preterm/low birth weight infant formula for special medical purpose

国食注字TY20185003

2023.6.25

8

ABBOTT NUTRITION, ABBOTT LABORATORIES

Similac Gro preterm/low birth weight infant formula for special medical purpose

国食注字TY20185004

2023.6.25

9

MEAD JOHNSON B.V.

Enfagrow infant lactose free formula (powder) for special medical purpose

国食注字TY20185005

2023.7.22

10

NESTLE NEDERLAND B.V.

早瑞能恩 preterm/low birth weight infant formula for special medical purpose

国食注字TY20185006

2023.7.22

11

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

乐赋 electrolyte formula for special medical purpose

国食注字TY20180002

2023.7.22

12

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

乐棠 electrolyte formula for special medical purpose

国食注字TY20180003

2023.7.22

13

ABBOTT MANUFACTURING SINGAPORE PRIVATE LIMITED

Pediasure nutritionally complete food for special medical purpose

国食注字TY20185007

2023.8.2

14

MEAD JOHNSON B.V.

Enfapro preterm/low birth weight infant formula (powder) for special medical purpose

国食注字TY20185008

2023.8.13

15

SYNUTRA INTERNATIONAL INC

优博敏佳 partially hydrolyzed milk protein formula for special medical purpose

国食注字TY20180004

2023.8.13

16

SYNUTRA INTERNATIONAL INC

优博安能 preterm/low birth weight infant formula for special medical purpose

国食注字TY20180005

2023.8.13

17

ABBOTT LABORATORIES S.A.

ABBOTT Similac preterm/low birth weight infant formula (powder) for special medical purpose

国食注字TY20185009

2023.10.7

18

MILUPA GMBH

Nutricia preterm/low birth weight infant formula for special medical purpose

国食注字TY20185010

2023.10.7

19

SHS INTERNATIONAL LTD

Periflex Ad. phenylketonuria formula (powder) for special medical purpose

国食注字TY20185011

2023.12.19

20

NESTLE NEDERLAND B.V.

ALFARE infant extensively hydrolyzed milk protein formula for special medical purpose

国食注字TY20185012

2023.12.19

21

ABBOTT NUTRITION

Similac HMFortifi infant nutrition supplement for special medical purpose

国食注字TY20185013

2023.12.19

22

Nestlé Deutschland AG

早启能恩 preterm/low birth weight infant formula for special medical purpose

国食注字TY20195001

2024.01.23

23

Nestlé Deutschland AG

NAN H.A. partially hydrolyzed milk protein formula for special medical purpose

国食注字TY20195002

2024.01.23

24

NESTLE NEDERLAND B.V.

安儿宁能恩 infant lactose free formula for special medical purpose

国食注字TY20195003

2024.01.23

25

Nestle Health Science China

佳膳佳立畅 nutritionally complete food for special medical purpose

国食注字TY20190001

2024.6.10

26

SYNUTRA INTERNATIONAL INC

优博启能 infant nutrition supplement for special medical purpose

国食注字TY20190002

2024.6.13

27

Nestlé Suisse SA, factory Konolfingen

PEPTAMEN JUNIOR nutritionally complete food for special medical purpose

国食注字TY20195004

2024.6.13

28

Du’erbote Yili Dairy Co. LTD

焕初 nutritionally complete food (powder) for special medical purpose

国食注字TY20190003

2024.6.18

29

HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.

贝新尔 preterm/low birth weight infant formula for special medical purpose

国食注字TY20190004

2024.6.18


30

ABBOTT MANUFACTURING SINGAPORE PRIVATE LIMITED

ENSURE COMPLETE® nutritionally complete food for special medical purpose

国食注字TY20195005

2024.6.26

31

Nestlé Suisse SA, factory Konolfingen

NUTREN JUNIOR nutritionally complete food for special medical purpose

国食注字TY20195006

2024.6.26

32

Nestlé Suisse SA, factory Konolfingen

NUTREN OPTIMUM nutritionally complete food for special medical purpose

国食注字TY20195007

2024.6.26

33

Maeil Dairies Co., Ltd

爱思诺赋儿嘉 infant lactose free formula for special medical purpose

国食注字TY20195009

2024.6.27

34

Maeil Dairies Co., Ltd

爱思诺晨而慧 preterm/low birth weight infant formula for special medical purpose

国食注字TY20195008

2024.6.27

35 HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.
昔倍护 infant nutrition supplement for special medical purpose
国食注字TY20190005
2024.7.29
36 Tianjin Aumix Dairy Co. LTD
力诺康宁 infant lactose free formula for special medical purpose
国食注字TY20190006 2024.10.13
37 SYNUTRA INTERNATIONAL INC
优博启瑞 nutritionally complete food for special medical purpose
国食注字TY20190008 2024.10.21
38 Nantong Richen Bioengineering Co. LTD
力存优太 nutritionally complete food for special medical purpose
国食注字TY20190007 2024.10.21
39 Nestle Nederland B.V.
Althera infant extensively hydrolyzed milk protein formula for special medical purpose
国食注字TY20195010 2024.10.21
40 Wyeth Nutritionals Ireland Ltd.
Wyeth® ULTIMA® 蔼而嘉 preterm/low birth weight infant formula for special medical purpose
国食注字TY20195011 2024.10.29
41 SYNUTRA INTERNATIONAL INC
优博瑞安 infant lactose free formula for special medical purpose
- -

Note: 1. the general names in the table are updated according to the Notice on the Adjustment of General Name of FSMP

          2. "舒乐加" (SUZHOU HENGRUI JIANKANG) changed its name to "乐赋" on August 23, 2019

There are totally 13 companies obtaining FSMP registration certificates, while among the 41 products, 10 of them have been developed by one company – Nestle. Moreover, there are 6 domestic companies obtaining FSMP certificate in China.

Food,China,Registration,Special,Medical,Purpose,Formula

Figure 1. Quantity of approved FSMP products at different companies

Among the 41 products, in terms of product type, as shown in the figure below, 29 of them are infant formula for special medical purposes, 3 are nutritionally incomplete food, and 9 are nutritionally complete food. While specific nutritionally complete food have not been approved until now. 


Figure 2. The approved products in different categories

 The detailed information are shown in table 2.

Table 2. Summary of the categories/types of the approved products

Categories/types

Amount being approved

Product/Company

Adapted population

FSMP for infants under the age of 12 months 

Extensively hydrolyzed milk protein formula or amino acid-based formula food

3

Neocate / SHS

ALFARE/ NESTLE 

Althera/ NESTLE

0-12 months

Partially hydrolyzed milk protein formula food

5

Eleva Care / ABBOTT

Similac / ABBOTT

EnfaGentlease / MEAD JOHNSON

优博敏佳/ SYNUTRA

NAN H.A./Nestle

0-12 months

Lactose free formula or low lactose formula food

6

Beingmate / HANGZHOU BEINGMATE

Enfagrow / MEAD JOHNSON

安儿宁能恩/ Nestle

爱思诺赋儿嘉/ Maeil Dairies

力诺康宁/Tianjin Aumix

优博瑞安/ SYNUTRA

0-12 months

Amino acid metabolism disorder formula food

1

Periflex / SHS

0-12 months

Premature or low birth weight infant formula food

11

Similac Neo / ABBOTT

Similac Gro / ABBOTT

早瑞能恩/ NESTLE

Enfapro/ MEAD JOHNSON

优博安能/ SYNUTRA

Similac/ ABBOTT

Nutricia/ MILUPA

早启能恩/ Nestle

爱思诺晨而慧/ Maeil Dairies

贝新尔/ HANGZHOU BEINGMATE

Wyeth® ULTIMA® 蔼而嘉/Wyeth

0-12 months

Infant nutrition supplement

3

Similac HMFortifi/ ABBOTT

优博启能/ SYNUTRA

昔倍护/ HANGZHOU BEINGMATE

0-12 months

FSMP for people over the age of 12 months

Nutritionally complete foods

9

Pediasure / ABBOTT

佳膳佳立畅/Nestle

小佰太能/Nestle

焕初/Yili Group

ENSURE COMPLETE®/Abbott

NUTREN JUNIOR /Nestle

NUTREN OPTIMUM /Nestle

优博启瑞/ SYNUTRA

力存优太/ Nantong Richen


1-10 year-old or above 10 years old

Specific nutritionally complete foods

0

NA

NA

Nutritionally incomplete foods

Electrolyte formula

2

乐赋/ SUZHOU HENGRUI JIANKANG

Above 10 year-old

乐棠/ SUZHOU HENGRUI JIANKANG

Above 18 year-old

Nutrient components

0

NA

NA

Thickening components

0

NA

NA

Liquid formula

0

NA

NA

Amino acid metabolism disorder formula

1

Periflex Ad./SHS

Above 10 year-old

The above information are analysis associated with the current situation of FSMP registration in China. Click to know more about FSMP registration requirements in China.

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